Full Text View
Tabular View
No Study Results Posted
Related Studies
Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
This study has been completed.
Study NCT01017783   Information provided by University of North Carolina, Chapel Hill

First Received on November 19, 2009.   Last Updated on August 1, 2011   History of Changes

November 19, 2009
August 1, 2011
March 2008
December 2009   (final data collection date for primary outcome measure)
Weight change [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017783 on ClinicalTrials.gov Archive Site
  • urine specific gravity [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 0, 3, 6 months ] [ Designated as safety issue: No ]
Same as current
 
 
 
Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults
Randomized Controlled Trial of a Water Beverage Intervention for Promoting Modest Weight Reduction in Free Living Adults

The primary objectives of this clinical trial are to determine if replacing sugar sweetened beverages with water consumption promote weight loss over 6 months in overweight adults and if replacing sugar sweetened beverages with water consumption promote greater weight loss over 6 months relative to replacement with other non-caloric sweetened beverages or control.

The secondary objective is to identify mediators and moderators of the effect of water replacement including hydration status, glucose metabolism, anthropometrics, physical activity, dietary intake and resting metabolic rate.

 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Behavioral: Dietary substitution A
    Substitution of calorie-dense item with lower calorie choice A
  • Behavioral: Dietary Substitution B
    Substitution of calorie-dense item with lower calorie option B
  • Behavioral: Healthy Choices
    Multiple healthy choices presented with self-selection of choices used
  • Healthy Choices
    Intervention: Behavioral: Healthy Choices
  • Experimental: Diet Substitution A
    Intervention: Behavioral: Dietary substitution A
  • Experimental: Diet Substitution B
    Intervention: Behavioral: Dietary Substitution B
Tate DF, Turner-McGrievy G, Lyons E, Stevens J, Erickson K, Polzien K, Diamond M, Wang X, Popkin B. Replacing caloric beverages with water or diet beverages for weight loss in adults: main results of the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2012 Mar;95(3):555-63. Epub 2012 Feb 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years of age.
  • Body mass index (BMI) between 25.0-49.9 kg/m2.
  • Subject consumes at least 280 calories per day from caloric beverages.

Exclusion Criteria:

  • Report losing >5% of current body weight in the previous 6 months.
  • Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
  • Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
  • Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
  • Report hospitalization for psychiatric problems during the prior year.
  • Report major psychiatric diagnoses and organic brain syndromes.
  • Report heart problems, chest pain, cancer within the last 5 years
  • Being treated by a therapist for psychological issues or problems with psychotropic medications.
  • Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
  • Unwilling to change intake of beverages during the study period.
  • Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
  • Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
  • Report not being able to attend group meetings on Monday or Tuesday evenings.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01017783
UNC-Nestle-01
No
Deborah F. Tate, PhD, The University of North Carolina at Chapel Hill
University of North Carolina, Chapel Hill
Nestle Waters North America, Inc
Principal Investigator: Deborah F Tate, PhD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP